A recent ruling by the European Medicines Agency that the benefit-risk profile of Pfizer Inc.'s antidepressant Endronax (reboxetine) was positive contradicts the outcome of a similar assessment a year ago by German health technology assessment body IQWiG, which had rubbished the drug as “ineffective and potentially harmful.” But it’s far from clear that Pfizer will now have any chance to resurrect the drug in Germany, however.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
